510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K974475Substantially Equivalent

Theraport Low-Profile Vascular Access System Models 1011 and 1012

Biocontrol Technology, Inc., Indiana PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K974475 is the FDA 510(k) clearance record for THERAPORT LOW-PROFILE VASCULAR ACCESS SYSTEM MODELS 1011 AND 1012, a class II device, cleared for Biocontrol Technology, Inc. on under FDA product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular). FDA records list 2 510(k) clearances for Biocontrol Technology, Inc., from to . As of , FDA records show no recalls naming K974475.

Clearance record

Decision date
Received
(96 days to decision)
Product code
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Regulation
21 CFR 880.5965
Device class
Class II
Review panel
General Hospital
Applicant
Biocontrol Technology, Inc. 300 Indian Springs Rd., Indiana PA
510(k) summary
Summary
Third party review
No

Clearances, product code LJT

Trailing 12 months
1 clearance under product code LJT in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LJT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260